BiCOAGRecalls & reported problems across all models

We found 4 models of BiCOAG by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2019 and Jun 26, 2025 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (16 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BiCOAG recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 19, 2026Open, Classified

   Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

   Z-3247-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Aug 19, 2026Open, Classified

   Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

   Z-3246-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Aug 19, 2026Open, Classified

   Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

   Z-3245-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Aug 19, 2026Open, Classified

   Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

   Z-3244-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. Jan 5, 2024Open, Classified

   The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

   Z-1481-2024 · Root cause: Employee error · Recall details · FDA record ↗

Most reported BiCOAG problems

BiCOAG models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BiCOAG CD-B622LA

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 recalls16 reports
• BiCOAG CD-B610LA

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall7 reports
• BiCOAG CD-B620LA

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall7 reports
• BiCOAG CD-B612LA

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall6 reports

Recent BiCOAG adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE HEMOSTATIC PROBE STOPPED WORKING. THE ISSUE WAS FOUND DURING A THERAPEUTIC BLEEDING CASE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337053 ↗
• InjuryJun 10, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING THERAPEUTIC HEMOSTASIS FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR A PAPILLOTOMY BLEED, THE 7FR FIXEDPIN HEMOSTATIC PROBE DETACHED AND FELL INTO THE SECOND PORTION OF THE DUODENUM, RESULTING IN A DELAY OF AROUND 30 MINUTES. THE PROBE TIP MEASURED 2 MM BY 6 MM. THE DEVICE COULD NOT BE LOCATED ENDOSCOPICALLY WITHIN THE PATIENT'S DUODENAL LUMEN AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE FROM ANOTHER COMPANY. AN X-RAY WAS PERFORMED ON THE SAME DAY, REVEALING THAT THE SUBJECT DEVICE HAD MIGRATED INTO THE JEJUNUM. IT HAS BEEN REPORTED THAT THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22180380 ↗
• InjuryOct 10, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE HEMOSTATIC PROBE TIP "BURNED OFF" DURING A DIAGNOSTIC COLONOSCOPY AND FELL INTO THE PATIENT'S COLON. THE DOCTOR RETRIEVED THE BROKEN TIP FROM THE COLON. THE PROCEDURE WAS EXTENDED MOMENTARILY AND ANOTHER PIECE OF EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE ISSUE DID NOT AFFECT THE DIAGNOSTIC OUTCOME OF THE PATIENT AND NO FURTHER INTERVENTION WAS NEEDED. THE PATIENT WAS REPORTED TO BE "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417633 ↗
• MalfunctionAug 21, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THE HEMOSTATIC PROBE DID NOT GENERATE ANY ENERGY AFTER BEING CONNECTED TO THE DIATHERMY. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010347 ↗
• MalfunctionJun 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THE SUBJECT DEVICE WAS EASILY STICKING TO THE TISSUE. THE EVENT WAS IDENTIFIED DURING A THERAPEUTIC GASTROINTESTINAL BLEEDING PROCEDURE, AND IT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623146 ↗
• MalfunctionJun 26, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE CERAMIC TIP OF BIOCOAG PROBE WAS EASY TO STICK TO THE TISSUE/WOUND. THE ISSUE WAS FOUND DURING A THERAPEUTIC GASTRO INTESTINAL (GI) BLEEDING IN THE MIDDLE OF A PROCEDURE THAT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613205 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588529 ↗
• InjuryJun 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) THE TIP OF THE HEMOSTATIC PROBE BROKE OFF AND LODGED INSIDE THE SCOPE CHANNEL. THE USER PUSHED IT OUT AND IT FELL INSIDE THE PATIENT'S STOMACH. THE FALLEN PIECE WAS NOT RETRIEVED. THE PROCEDURE WAS PROLONGED A FEW MINUTES AND COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO HARM TO THE PATIENT REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: Foreign Body In Patient

  MAUDE report 19567573 ↗
• MalfunctionJan 26, 2024

  BICOAG HEMOSTASIS PROBE 10 FR END BROKE IN SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586673 ↗
• MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS BICOAG HEMOSTASIS PROBE HAD A DETACHED TIP. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE FOR HEMOSTASIS OF A GASTROINTESTINAL BLEED OF THE DUODENUM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436342 ↗
• MalfunctionDec 22, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE HEMOSTATIC PROBE'S TIP BROKE OFF. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383869 ↗
• MalfunctionOct 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE 7FR COAX HEMOSTATIC PROBE FAILED OUT OF THE BOX AND CAUSED A SPARK WHEN ATTEMPTING TO BE USED. THE ISSUE OCCURRED DURING THE MIDDLE OF A THERAPEUTIC SMALL BOWEL ENTEROSCOPY WITH HEMOSTASIS AND ABLATION OF LESIONS. THE PATIENT HAD A HISTORY OF GASTROINTESTINAL BLEEDING AND SMALL BOWEL ANGIOECTASIA IDENTIFIED ON CAPSULE ENDOSCOPY. A SECOND GOLD PROBE WAS USED TO CONTROL THE LARGE AVM THAT BEGAN TO BLEED WITH MINIMAL MANIPULATION. NO MEDICAL INTERVENTION WAS REQUIRED AND NO OTHER DEVICES WERE CONNECTED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE TIP BROKE OFF. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904522 ↗
• MalfunctionAug 30, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT AFTER THE PROBE WAS REMOVED FROM THE SCOPE, THE NURSE USED GAUZE TO CLEAN THE TIP, THE TIP FELL OFF ON THE TROLLEY OF THE 7FR FIXEDPIN HEMOSTATIC PROBE. THE REPORTED ISSUE OCCURRED AT THE END OF THE THERAPEUTIC SAMPLING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY OR PATIENT HARM, OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17656614 ↗
• MalfunctionJun 12, 2023Break; Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS USED FOR A PROCEDURE (AN UNSPECIFIED), AFTER USE, THE NURSE HELPED TO TAKE IT OUT FROM THE SCOPE AND THE CERAMIC TIP FELL OFF ON THE TROLLEY WHEN THE NURSE WAS GENTLY CLEANING THE TIP. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17103896 ↗
• MalfunctionJun 2, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, WHILE HEALING PAPILLA BLEEDING, THE DEVICE (BICOAG PROBE) HEMOSTASIS TIP FELL OFF. ANOTHER BICOAG PROBE WAS OBTAINED, TRIED AND THE SAME ISSUE HAPPENED. BICOAG SETTINGS WERE BISOFTCOAG 40,EFFECT 1. THERE WAS NO PATIENT HARM OR INJURY REPORTED, FULLY COVERED STENT WHERE USED TO HEAL THE BLEEDING . NO USER INJURY REPORTED. THIS EVENT INCLUDES TWO REPORTS ADDRESSING THE TWO DEVICES (BICOAG PROBE) REPORTED IN THE EVENT. REPORT WITH PATIENT IDENTIFIER (B)(6) (BICOAG PROBE CD-B620LA LOT KR248637 ) . REPORT WITH PATIENT IDENTIFIER (B)(6) (BICOAG CD-B620LA LOT KR238330 ). THIS REPORT BEING SUBMITTED IS FOR PATIENT IDENTIFIER (B)(6) (BICOAG CD-B620LA LOT KR238330 ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046130 ↗

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